JP2018529447A - Filling aid - Google Patents

Abstract

It is possible to transfer a medical liquid or a pharmaceutical liquid from a container into a cylinder ampoule or carpulp in a simple manner. A first housing part (24) formed so as to house a cylinder ampoule (7) to be filled in a common housing (4), and a container containing a medical substance or a pharmaceutical substance ( 18) and a second housing part (26) formed to house the cylinder ampoule (7) in the first housing part (24). A first access opening (28) is formed so as to face the opening of the cylinder ampoule when inserted into the container, and the second container (26) has the container A second access opening (30) is formed so as to face the opening of the container (18) when (18) is inserted into the second accommodating part (26). [Selection] Figure 1

Description

  The present invention relates to a filling aid for filling a cylinder ampoule and a method for filling a cylinder ampoule using such a filling aid.

  In various medical applications, it is necessary to transfer medical or pharmaceutical liquids from containers into cylinder ampoules, so-called carpules. This is especially the case when the aforementioned liquids must be pre-dissolved, for example by adding a liquid solvent such as saline or saline for injection, which is originally dry, especially in powder form. That's right.

  Such cylinder ampules or carpules are in particular those used in so-called “pen systems” or carpule syringes and are also intended for home use. Such pen systems are well known, especially for insulin, but can also be used for other medical or pharmaceutically active substances, for example hormonal preparations for children and adolescents. The active substance is usually in powder form and is first dissolved as described above, then transferred into a cylinder ampoule or carpul, and then inserted into a cylinder ampoule carpule syringe or pen system. This is not easy for medical amateurs. In particular, in such a process, it is essential to maintain sterility, which is a problem.

  In view of such problems, an object of the present invention is to provide a filling aid for filling a cylinder ampoule that allows a medical or pharmaceutical liquid to be transferred from the container into the cylinder ampoule or carpule in a simple manner. Is to provide.

  This object is achieved by a filling aid with the features of claim 1 and a method with the features of claim 17. Preferred embodiments will become apparent from the dependent claims, the following description and the accompanying drawings.

  The filling aid according to the invention serves to transfer a medical or pharmaceutical liquid from a container into which the liquid is injected or mixed into a cylinder ampoule. This filling aid can be used for various medical liquids or pharmaceutical liquids.

  The filling aid according to the invention comprises at least one holding aid as the main element. This filling auxiliary tool includes a housing in which a first accommodating portion is formed. The first accommodating portion is formed so as to accommodate a cylinder ampoule to be filled. In other words, the first housing part is preferably sized and shaped so as to accommodate a cylinder ampoule to be filled, such as a cylinder ampoule for a general cartridge syringe. Such a cylinder ampoule is known in the market under the name Carpul. Further, a second housing portion is provided in the housing, and is formed so as to house a container into which medical liquid or pharmaceutical liquid is injected. In other words, the second container is dimensioned and shaped so that a common container for containing a medical substance or pharmaceutical substance can be inserted and contained therein. This container is in particular a general medicine bottle. Instead of providing a complete medical or pharmaceutical solution in the container, the container is first added with a solvent such as saline or saline to produce the medical or pharmaceutical liquid. It may have medical substances or pharmaceutical substances that need to be dissolved. In that case, the dissolution is preferably performed in the filling aid, that is, in a state where the container is accommodated in the second accommodating portion.

  A first access opening is formed in the first housing portion. The first access opening is formed so as to face the opening of the cylinder ampoule when the cylinder ampoule is inserted into the first housing portion. That is, since the opening of the inserted cylinder ampule or the diaphragm that closes the opening can be accessed from the outside through the first access opening, the cylinder ampule disposed in the housing of the filling aid through the first access opening. Can be filled. Further, the housing includes a second access opening disposed in the second housing portion. The second access opening is designed and arranged to face the opening of the container or the stopper that closes the opening when the container is inserted into the second receiving portion. That is, the container opening or plug (eg, a septum) is accessible through the second access opening when the container is inserted into the second receptacle, so that, for example, the powder can be passed through the second access opening. It is possible to bring the solvent into the container into the container and / or to remove the contents of the container from the container.

  The embodiment of the filling aid according to the invention has the advantage that both the source and destination elements of the medical or medicinal liquid can be securely held in one component, ie the holding aid. Therefore, the filling aid can simultaneously hold the container in which the liquid is mixed or prepared therein and the cylinder ampoule to be filled. This simplifies handling because the liquid can be transferred from the container into the cylinder ampoule using, for example, a syringe. In this case, the syringe is first inserted into the second access opening to accommodate the contents of the container in the syringe. The syringe is then replaced from the second access opening to the first access opening and the contents are transferred from the syringe into the cylinder ampoule. At that time, the filling aid or its holding aid holds the cylinder ampule and the container so that the opening of the cylinder ampule and the container, in particular, the opening is protected and contamination is prevented. After the liquid has been transferred into the cylinder ampoule, the cylinder ampoule can be removed from the first receptacle and inserted into a carpul syringe or a conventional pen system, for example. Such a design is advantageous not only for use by the patient himself, but also for example in clinics, doctors' surgery and laboratory use.

  The housing of the filling aid according to the invention is preferably made of plastic, more preferably as a single structure, in particular as an integral plastic part. The housing may be produced in particular as a plastic injection-moulded part, which enables low-cost production.

  Preferably, a fixing means is arranged in the first housing part. The fixing means is formed and provided so as to removably fix the cylinder ampoule in the first housing portion. The securing means is preferably configured to hold a general, i.e. standardized, cylinder ampoule or carpule. The securing means is configured and arranged to retain the cylinder ampoule within the receiving portion when the syringe is inserted through the first access opening to fill the cylinder ampoule. Furthermore, the fixing means is also formed so that the cylinder ampoule can be removed from the accommodating portion. For this reason, it can be said that the cylinder ampoule is gripped and the force acting on the cylinder ampoule exceeds the holding force of the fixing means. Here, the direction in which the cylinder ampule is removed from the first housing portion preferably extends in the longitudinal direction of the cylinder ampule. More preferably, this is also at the same time the insertion direction in which the syringe is inserted into the first access opening for coupling with the opening of the cylinder ampoule to bring liquid from the syringe into the cylinder ampoule. The fastening means is preferably formed as a force-coupled and / or shape-coupled fastening element, preferably gripping the cylinder ampoule at the front end, ie the end adjacent to the opening. More preferably, the fixing means may be formed as a latch hook or a latch tongue. In particular, the latch hook or latch tongue may engage around or behind the collar surrounding the opening. In doing so, the latch hooks or latch tongues are preferably configured to disengage from their locking positions and release the cylinder ampules when a sufficiently large force is applied in the longitudinal direction of the cylinder ampules. This type of latch tongue or latch hook is preferably of a unitary construction and is integrally formed with at least a portion of the housing, preferably the entire housing. In particular, when the housing is made of plastic, such latch hooks or latch tongues can be formed together in a simple manner.

  According to a particularly preferred embodiment, the filling aid is formed in such a way that the cylinder ampoule is pre-assembled by a fixing means and is removably fixed in the first housing part and removable from the first housing part. Has been. Thus, the filling aid is delivered to the user with the cylinder ampoule pre-assembled so that the user no longer has to insert the cylinder ampoule into the filling aid. This has the advantage that handling is further simplified and that the cylinder ampoule is securely protected and secured in the filling aid.

  According to a further preferred embodiment, a fixing means is arranged in the second housing part, the fixing means being adapted to removably fix the container containing the medical substance or the medicinal substance in the housing part. Formed and provided. Such a container may be a medicine bottle common in the medical field. That is, the securing means is preferably dimensioned and formed so that such a vial can be secured. The fixing by the fixing means is preferably such that the container can be taken out from the second accommodating portion and released by releasing the fixing by applying a sufficient force. In this case, the removal direction is preferably located so as to correspond to the longitudinal axis or central axis of the container, which longitudinal axis or central axis preferably also corresponds to the insertion direction of the syringe into the second access opening. doing. The securing means is preferably formed as a latch hook or latch tongue that engages behind the collar. This type of collar, in the case of a typical container, is formed at the shaft end where the opening is located and surrounds and / or holds the stopper of the container. The latch tongue or latch hook is preferably formed in a single structure or integrally with at least a part of the housing, preferably all of the housing. Therefore, this latch hook can be manufactured by injection molding together with the housing at low cost. The latch hook or latch tongue is preferably set so that when a sufficiently large force is applied to the container, it can be moved from the locked position to the released position to remove the container from the second receptacle. ing. However, more preferably, the container and the medical substance or the pharmaceutical substance, the medical liquid, or the pharmaceutical liquid can be shipped separately from the factory. In this case, the container must first be inserted by the user into the second housing, where it is preferably fastened and / or clamped by a fixing means. After the medical or pharmaceutical liquid is removed from the container in the manner described above, the container may no longer be needed and may remain in the second container. Alternatively, if the fixing means in the second accommodating part is formed so that the fixation can be released, the container can be taken out from the second accommodating part by the user again, for example, for the separation and disposal process. Also good.

  According to a further preferred embodiment, a cannula element is removably retained in the second receptacle. The cannula element includes a cannula and a luer connector. Here, the cannula element is positioned in the second receptacle so that the luer connector of the cannula faces the second access opening and the cannula enters into the container inserted in the second receptacle. Is arranged. The cannula element is used to enter the opening of the container by means of a cannula, in particular for piercing a filling, for example a septum, in the opening of the container.

  Particularly preferably, the cannula element is arranged in a linear guide in the second receptacle, which linear guide allows movement of the cannula element in the longitudinal direction of the cannula element, ie in the longitudinal direction of the cannula. Here, the cannula element is movable in a linear guide between a first position and a second position. The cannula element is closer to the second access opening in the first position than in the second position. The second position is located so that the cannula enters the container at this position, i.e. in particular pierces the septum of the container. In the initial state of the filling aid, i.e. the factory state, the cannula element is preferably in the first position, in which the cannula does not enter the part of the receiving space where the container is accommodated. . Preferably, a locking or locking portion of the cannula element is provided in the first position so as to be unlocked by the action of force. In use, a syringe having a luer taper is inserted into the second access opening such that the luer taper engages the cannula luer connector. When the syringe is pushed further into the second access opening, the cannula element is moved from the first position to the second position, preferably in which case the locking or clamping part there is unlocked. . This pushes the cannula of the cannula element into the container.

  More preferably, at least one holding means is arranged in the second receiving part, the holding means removably fixing the cannula element. Here, the holding means generates a holding force that is less than the force that can be transmitted in the longitudinal direction of the cannula, preferably in the longitudinal direction by the luer connector, ie, the traction force that can be transmitted. At the same time, the holding means can fulfill the function of the locking part or the fastening part. The retaining means prevents the cannula element from falling out of the second access opening. In use, after the liquid has been transferred from the container into the syringe inserted using the cannula element, the cannula element is withdrawn from the second access opening along with the syringe. At that time, the holding force of the holding means is released. In other words, the connection between the luer taper and the luer connector must be maintained so that the pulling force for releasing the holding force of the holding means is transmitted.

  The second access opening is preferably dimensioned so that the cannula element can be removed through the second access opening. The cannula element is also withdrawn from the second access opening, preferably with a syringe attached to the cannula element.

  Thereafter, in the next step, preferably the syringe is inserted with the cannula element into the first access opening, with the cannula entering the opening of the cylinder ampoule held or fixed in the first receptacle. At this time, the cannula preferably pierces the stopper of the cylinder ampoule, in particular the septum. Here, the first access opening and the first receiving part are preferably formed and arranged so that the cannula element is guided linearly within the first receiving part in order to ensure the piercing of the diaphragm of the cylinder ampoule. Has been. More preferably, a guide is provided for guiding the cannula element so that the cannula enters the diaphragm off the center of the diaphragm. This has the advantage that a good seal is maintained in this area, since the point of the diaphragm which is subsequently pierced in the pen system has not already been pierced by the cannula during filling.

  According to a preferred embodiment of the present invention, a syringe having a luer taper, separate from the housing, is a component of the filling aid. The syringe is configured such that the luer taper engages the luer connector of the aforementioned cannula element. The syringe may be prepared as an empty syringe, or it may be pre-filled with a liquid for dissolving the medical or pharmaceutical substance in the container, for example saline for injection or saline. . This syringe is then used as described above to transfer medical or pharmaceutical fluid from the container into the cylinder ampoule. In some cases, the liquid contained in the syringe may first be pushed into the container where the dried material is dissolved to produce the desired liquid. After thorough mixing, this liquid is preferably aspirated from the container by the same syringe. The syringe is then removed from the second access opening as described above with the cannula element and inserted into the first access opening, and then the liquid is transferred into a cylinder ampoule held in the first receptacle.

  According to a special embodiment of the present invention, a third housing part formed for housing and fixing the syringe may be formed in the housing. This third receptacle allows the used syringe to be inserted into the third receptacle and discarded with the filling aid. Preferably, the third receiving part is formed only for receiving and securing the syringe, and particularly preferably the cannula element remains in or near the first access opening after use as will be described later. It is good.

  Preferably, the first access opening is dimensioned such that a cannula element, preferably the aforementioned cannula element, can be inserted through the first access opening into the first receptacle. This enables the cannula of the cannula element to be inserted into the first access opening for introduction or insertion into the cylinder ampoule to be filled after the syringe has been removed from the second access opening with the cannula element become.

  More preferably, at least one securing means is arranged beside the first access opening in the first housing portion. This securing means is configured to secure, preferably non-removably secured, the cannula element inserted through the first access opening. This allows the syringe to be removed from the first access opening after introducing liquid into the cylinder ampoule, while the cannula element is securely stored for disposal while remaining fixed therein. Accordingly, the securing means is preferably configured to be able to break through in the direction of insertion and to lock in the opposite direction of movement. This can be achieved, for example, by an elastic latch tongue or retaining projection, preferably formed integrally with at least one housing part. This may be, for example, the housing described above, or a component connected to the housing, for example a closing element described below.

  According to a further preferred embodiment of the invention, the filling aid comprises a closure element which is movable between a first position and a second position, which closure element is in the first position. The first access opening is closed and the second access opening is opened, and in the second position, the second access opening is closed and the first access opening is opened. The closure element serves for safe handling as it opens only one access opening each time in the correct sequence of use. That is, in the factory state, the closure element is preferably in the first position, so that the syringe can first be inserted into the second access opening. Thereafter, the closure element is moved to the second position after the syringe is preferably removed from the second access opening. This opens the first access opening and the syringe is now inserted into the first access opening, preferably with the attached cannula element. The closure element is preferably formed as a plastic injection-molded part, like the housing described above, and is movably connected to the housing. This may be done, for example, by a latching system. Thereby, the housing and the closure element can be formed by only two components. In this case, it is preferable that all the components of the housing described above, in particular the holding means, the securing means, the fixing means, the locking portion and / or the fastening portion, are formed integrally with the housing.

  The securing means of the cannula element in the first access opening described above may preferably be formed in the closure element by a latch hook or a latch tongue. Thereby, the cannula element is secured between the closure element and the housing after being inserted into the first access opening.

  More preferably, the closure element comprises at least one releasable lock, which locks releasably secure the closure element in the first position and / or the second position. The locking part is preferably releasable with one hand. Such a locking part prevents the closure element from being unintentionally displaced from the first position to the second position. Such a locking part may be formed in the housing, for example by a protrusion arranged on the elastic tongue, which protrusion when the closing element is in the first position, in particular the displacement of the closing element. Before the front edge in the direction. The protrusion thus prevents the closure element from moving. For the movement of the closing element, the closing element must be disengaged from the edge via the elastic tongue so that it can be moved, in particular displaced. More preferably, the locking part may be configured to engage the closure element in a suitable manner also in the second position of the closure element in order to secure the closure element in the second position. For this purpose, preferably, the closure element may be formed with a recess or opening into which the protrusion of the elastic latch tongue engages. Such a locking arrangement is such that the protrusion engages the recess of the closure element in the first position of the closure element and the rear edge of the closure element in the displacement direction in the second position of the closure element or You may carry out by the reverse method of being located near another recessed part. Particularly preferably, two such locks are provided, which are on opposite sides of the housing and must be pushed with a finger in order to displace the closure element.

  More preferably, the closing element is guided displaceably by a guide of the housing. In so doing, the guide is preferably straight and extends transversely to the direction of insertion of the syringe into the first and second access openings. Particularly preferably, the guide and the displacement direction defined by the guide extend obliquely rather than perpendicular to the aforementioned insertion direction. As a result, the closure element is displaced not only laterally with respect to the insertion direction but also to some extent in the insertion direction when displaced from the first position to the second position. The closure element may be provided with an opening that covers the first access opening in the second position. This opening also serves to guide the syringe at the same time. When the closure element is displaced from the first position to the second position, if the closure element is also moved axially in the insertion direction, the guide constituted by this opening is moved to another axial position . This is advantageous because the cylinder ampoule to be filled is usually longer in the axial direction than the aforementioned container, in particular a vial. In this way, it is possible to make the filling aid, particularly the factory-shipped state, particularly small. In the factory state, the closure element is in a first position designated for inserting the syringe into the container. The axial length of the filling aid required for the guide to insert the syringe into the cylinder ampoule is only brought about by the displacement of the closure element to the second position, whereby the filling aid is axially moved. become longer.

  The first and second access openings are preferably located on the same side of the housing. Thereby, handling becomes easy. This is because there is no need to change the orientation of the housing, and the syringe can be replaced from the first access opening to the second access opening on the same side.

  More preferably, the first housing part having the first access opening and the second housing part having the second access opening are such that the insertion directions of the first and second access openings extend parallel to each other. Arranged and formed, the cannula element and / or syringe can be inserted or removed from the access opening along this insertion direction. This also facilitates handling. This is because it is not necessary to change the angular position of the housing when the syringe is pulled out and inserted.

  A further subject matter of the invention is a method of filling a cylinder ampoule with a medical or pharmaceutical liquid using a filling aid as described above. The main method steps are described below. Further details about the course of the method have already been described in connection with the formation of filling aids. Refer to these embodiments for methods.

  According to this method, a container having a medical liquid or a medical liquid to be transferred to a cylinder ampoule is first prepared. This container has been inserted into the second housing part of the housing of the filling aid or has already been inserted there in the factory state. In the next step, a syringe is inserted into the second access opening by the second receptacle in the housing and in fluid communication with the interior of the container. This is preferably done in such a way that the cannula of the cannula element already assembled and held in the second receptacle is inserted into the opening of the container, as described above. In the next step, a medical or pharmaceutical liquid is transferred from the container into the syringe. This is done in particular by aspiration using a syringe. However, the container may alternatively be provided with a piston, and therefore the transfer may be performed by applying pressure to the piston within the container. After transfer of the liquid into the syringe, the syringe is removed from the second access opening, in which case a cannula element, preferably located beside the syringe, may be removed together. Thereafter, the syringe is inserted into the first access opening, possibly after displacing the closure element in advance. In so doing, if there is a cannula element, the aforementioned cannula is inserted into the opening of the cylinder ampoule. Then, the medical liquid or the pharmaceutical liquid is pushed from the syringe into the cylinder ampoule disposed in the first housing portion. Since the cylinder ampoule is preferably assembled in advance and held in the first housing portion, the filling aid with the cylinder ampoule assembled is shipped from the factory. After the liquid has been transferred from the syringe into the cylinder ampoule, the cylinder ampoule is removed from the first receptacle and inserted into a carpul syringe or pen system in a well-known manner. The syringe may be removed from the first access opening, as described above, preferably while the cannula element remains in the receptacle. In some cases, the syringe may then be inserted into the third housing as described above.

  According to a particular embodiment of the method, the container may contain a medical substance or a pharmaceutical substance initially in powder form, for example freeze-dried, which is dissolved by the addition of a liquid. The aforementioned medical liquid or pharmaceutical liquid is produced in the container. For this, preferably, when the syringe is inserted into the second access opening, the syringe pushes a solvent, such as saline or saline for injection, into the container, followed by the substance in the container. It is dissolved by the liquid. This may be done by shaking in some cases. After successful mixing or dissolution, the medical or pharmaceutical liquid thus produced is preferably transferred again into the same syringe as described above. The syringe is then removed from the second access opening as previously described and inserted into the first access opening.

  The advantage of the method according to the invention is that the medical or medicinal liquid is not sucked by the movement of a movable stopper in the cylinder ampoule, as is customary in conventional cylinder ampoule filling, but from the syringe into the cylinder ampoule. It is to be pushed. This is advantageous because it prevents unwanted bubbling of the liquid. In order to prevent foaming during the transfer from the container into the syringe, the container may be formed with a movable piston, and the movable piston is pushed into the syringe attached from the container. Push in.

Hereinafter, the present invention will be described by way of example with reference to the accompanying drawings.
1 shows the main part of a filling aid according to the invention having a container for a medical or medicinal liquid and a cylinder ampoule. FIG. 6 is a perspective view showing a housing of a filling aid with a closure element attached thereto. It is a side view of the housing shown in FIG. FIG. 4 is a top view of the housing shown in FIG. 3. FIG. 6 is a side view of a housing shown without a closure element. FIG. 6 is a side view of the housing shown in FIG. 5 as viewed from one of the end faces. It is the VII-VII sectional view taken on the line of the housing shown in FIG. FIG. 6 is a perspective view showing a closure element. It is a perspective view which shows the filling auxiliary tool of the state in which the cylinder ampoule and the container were inserted. It is explanatory drawing which shows use of the filling auxiliary tool by this invention in steps. It is explanatory drawing which shows use of the filling auxiliary tool by this invention in steps. It is explanatory drawing which shows use of the filling auxiliary tool by this invention in steps. It is explanatory drawing which shows use of the filling auxiliary tool by this invention in steps. It is explanatory drawing which shows use of the filling auxiliary tool by this invention in steps. It is explanatory drawing which shows use of the filling auxiliary tool by this invention in steps. It is explanatory drawing which shows use of the filling auxiliary tool by this invention in steps. It is explanatory drawing which shows use of the filling auxiliary tool by this invention in steps. It is explanatory drawing which shows use of the filling auxiliary tool by this invention in steps. It is explanatory drawing which shows use of the filling auxiliary tool by this invention in steps. It is explanatory drawing which shows use of the filling auxiliary tool by this invention in steps. It is a perspective view which shows the filling auxiliary tool after filling a cylinder ampoule.

  The filling aid shown here by way of example has two main components: a holding device 2 formed by a housing 4 fitted with a closure element 6 in one part and a syringe 8 in another. Prepare. The holding device 2 is used to accommodate a cylinder ampoule 7 to be filled. As usual, the syringe 8 is formed of a cylinder 10 having a piston 11 that can move through a piston rod 12 therein. The syringe 8 is provided with a luer taper 14 at its end, and in the example shown in FIG. 1, a cap 16 is put on the luer taper 14.

  The filling aid according to the invention serves to transfer medical or pharmaceutical liquids from the container 18 into the cylinder ampoule 7. The container 18 shown here is an ordinary medicine bottle or injection vial, and is sealed by a stopper or diaphragm 20 on the upper side. A collar 22 is formed in the container 18 so as to surround the diaphragm 20. The housing 4 includes a first accommodating portion 24 and a second accommodating portion 26, and the first accommodating portion 24 is formed so as to accommodate the cylinder ampoule 7, and the second accommodating portion 26 is a container 18. Is shaped and dimensioned to accommodate. The first accommodating portion 24 and the second accommodating portion 26 are open toward the same side portion of the housing 4 and have insertion directions E1 and E2 parallel to each other. The containers 18 are inserted into the first storage portion 24 and the second storage portion 26, respectively. The first accommodating portion 24 is provided with a first access opening 28 that opens to the end surface of the housing 4 in the insertion direction E1. Therefore, the second accommodating portion 26 is provided on the same side as the first access opening 28 and has a second access opening 30.

  An elastic latch tongue 32 formed integrally with the housing 4 is disposed in the first accommodating portion 24 in the vicinity of the first access opening 28. These latch tongues 32 are arranged and formed so that a collar 34 surrounding the stopper or diaphragm of the cylinder ampoule 7 can be wrapped in order to removably fix the cylinder ampoule 7 in the first housing 24. . When the cylinder ampoule 7 is fixed in the first accommodating portion 24 in this way, the opening of the cylinder ampoule 7 sealed by the diaphragm faces the first access opening 28.

  The latch tongue 32 constituting the fixing means is deformed radially outward from the first access opening 28 when a sufficiently large force is applied in the insertion direction E1, and the collar 34 can pass through the latch tongue 32. The ampules are arranged and formed so that they can be taken out from the first accommodating portion 24.

  A plurality of fixing means in the form of latch tongues 36 are arranged in the second housing part 26, and these fixing means are used to fix the container 18 in the second housing part 26. It is sized and arranged so that it can be engaged after the collar 22. Here, the latch tongue 36 having the protruding portion is formed so that the container 18 cannot be taken out from the second accommodating portion 26 again. That is, the latch tongue 36 expands only once when the container 18 is inserted into the second accommodating portion 26, and is not intended to remove the container 18 again. However, alternatively, the latch tongue 36 may be formed so that the container 18 can be removed again corresponding to the latch tongue 32.

  In the second housing part 26, a holding means 38 in the form of a fastening part is formed between the latch tongue 36 and the second access opening 30. The retaining means 38 is used for receiving and securing the cannula element 40. Here, the cannula element 40 is guided by the holding means 38 so as to be displaceable in the axial direction of the insertion direction E2. Cannula element 40 includes a luer connector 42 at the end facing the second access opening 30 and a cannula 44 at the opposite end. The cannula element 40 is displaceable in the insertion direction E2 between a first position shown in the partial view A1 of FIG. 12 and a second position shown in the partial view A2 of FIG. In the second position, the cannula 44 enters the septum 20 of the container 18, for example as shown in FIG. The second access opening 30 is dimensioned so that the cannula element 40 can be removed from the second access opening 30.

  The closing element 6 is formed as a displaceable slider on the housing 4 and engages two sides of the housing 4. That is, the closure element 6 has a U-shaped cross section and engages the housing 4 on two sides that are spaced apart from each other. The movement or displacement direction S of the closing element 6 extends transversely to the insertion directions E1 and E2. Here, the displacement direction S is not perpendicular to the insertion directions E1 and E2, but extends obliquely. For this purpose, the housing 4 is provided with one guide groove 46 extending in the displacement direction S on each of two side surfaces separated from each other. The closing element 6 includes one protrusion 48 that engages with the guide groove 46 on each of two inner surfaces facing each other (only one is visible in FIG. 8).

  The closure element 6 is configured to seal the first access opening 28 and open the second access opening 30 in the first position shown in FIGS. In this position, the closing element 6 is secured by the locking part so as not to be displaced unintentionally. This locking part is formed by two elastic tongues 50 on the two outer surfaces of the housing 4 which are separated from each other. The elastic tongue piece 50 is provided with a protruding portion 52 protruding outward at the free ends thereof. In the first position of the slider, these protrusions 52 each engage in the opening 54 of the closure element 6. In order to be able to displace the closure element 6 to the second position, it is necessary to push these two protrusions 52 from the outside to disengage the opening 54. Thereafter, in the second position, the elastic tongue piece 50 bounces back to the outside again, and the projecting portion 52 comes into contact with the side end portion 56 as shown in FIG. Accordingly, the closure element 6 is fixed in the second position. In this second position, the opening 58 formed in the end face of the closure element 6 faces the first access opening 28. The opening 58 is provided at its periphery with an elastic tongue 60 which constitutes a fixing means for holding the cannula element 40. The opening 58 and the elastic tongue 60 are dimensioned so that the cannula element 40 can pass through the opening 58 while the elastic tongue 60 extends radially. As the cannula element 40 passes through the opening 58, the elastic tongue 60 rebounds radially inward again, preventing the cannula element 40 from moving back.

  Next, the function of the filling aid according to the present invention will be described with reference to FIGS. In this embodiment, the container 18 is pre-filled with a powdered medical substance or pharmaceutical substance. The holding device 2 is shipped from the factory with the closure element 6 in the first position as shown in FIG. The cylinder ampoule 7 is assembled in advance in the first accommodating portion 24 of the housing 4. The cylinder ampoule 7 is then held by the latch tongue 32 in the manner described above. In this state, the movable piston 62 is in the position shown in FIG. 1, that is, in the vicinity of the opening or diaphragm of the cylinder ampoule 7 held by the collar 34. Furthermore, a cannula element 40 is preassembled in the housing 4. This cannula element 40 is initially in the first position shown in partial view A1 of FIG. In this state, the container 18 is fitted into the second accommodating portion 26 in the second insertion direction E2. At this time, since the latch tongue 36 spreads in the radial direction, the collar 22 can pass through the protrusion of the latch tongue 36, and is thereafter wrapped by the protrusion of the latch tongue 36. Therefore, the container 18 is fixed in the second accommodating portion 26.

  In the next step, after removal of the cap 16, the syringe 8 is inserted into the second access opening 30, as shown in FIG. At this time, the luer taper 14 of the syringe 8 engages the luer connector 42 of the cannula element 40. In this example, the syringe 8 is pre-filled with a liquid for dissolving a medical substance or a pharmaceutical substance, for example, physiological saline or saline for injection.

  As shown in FIG. 12, when the syringe 8 with the luer taper 14 is engaged with the cannula element 40, the syringe 8 is further advanced in the insertion direction E2, and the cannula element 40 is in the first position as shown in the partial view A2 of FIG. Move to a second position further away from the two access openings 30. In this position, the cannula 44 pierces the septum 20 of the container 18. In the next step, as shown in FIG. 13, the piston rod 12 of the syringe 8 is displaced, thereby injecting the contents of the syringe 8 through the cannula element 40 and into the container 18. In this way, the substance in the container 18 is dissolved. In this case, you may shake the holding | maintenance apparatus 2, ie, the housing 4, for melt | dissolution. In the next step, as shown in FIG. 14, the holding device 2 is turned with the inserted syringe 8 so that the piston rod 12 faces down. When the piston rod 12 of the syringe 8 is pulled in this state, the contents of the container 18 that is now a medical liquid or a pharmaceutical liquid are sucked into the syringe 8.

  In the next step, as shown in FIG. 15, the holding device 2 is reversed again and the syringe 8 together with the cannula element 40 is withdrawn from the second access opening 30 in the insertion direction E2. At that time, the cannula 44 is withdrawn from the diaphragm 20. For this purpose, it is necessary that the holding force in the holding means 38 is smaller than the fastening force between the luer taper 14 and the luer connector 42.

  In the next step, the closing element 6 is displaced along the displacement direction S on the housing 4 as shown in FIGS. 16 (a) and 16 (b). In this case, first, as shown in FIG. 16 (a), only the protrusion 52 (in FIG. 16 (a), the protrusion 52 on the front surface can be visually recognized, but another protrusion formed in the same manner on the back surface. 52) is pushed, thereby disengaging the protrusion 52 from the opening 54. Thereafter, the closing element 6 is displaced in the displacement direction S as shown in FIG. Here, one-handed operation is possible. That is, since the closing element 6 can be displaced while holding the closing element 6 in the region of the opening 54, the pushing of the protrusion 52 and the displacement of the closing element 6 can be carried out with one hand without re-handling. Can do. Thus, the closure element 6 reaches the second position shown in FIG. In this position, the protrusion 52 of the tongue piece 50 springs back again, thereby abutting against the side edge 56 of the closure element 6 to secure the closure element 6 in the second position shown.

  In this position, the syringe 8 together with the cannula element 40 with the cannula 44 is first inserted in the insertion direction E1 into the opening 58 of the closure element 6 and subsequently into the first access opening 28 of the housing 4 below it. Inserted. At this time, the cannula element 40 passes through the elastic tongue 60 of the opening 58 as described above. At the same time, the cannula 44 enters the cylinder ampoule 7 through the stopper or diaphragm. In this state, as shown in FIG. 18, the piston rod 12 of the syringe 8 is displaced in the insertion direction E <b> 2, and the contents of the syringe 8 are pushed or transferred into the cylinder ampoule 7. Here, the piston 62 is displaced in the cylinder ampoule 7 toward the end opposite to the opening of the cylinder ampoule 7. In the next step, as shown in FIG. 19, the cylinder ampoule 7 is pulled out from the first accommodating portion 24 in the insertion direction E1. At this time, since the latch tongue 32 spreads in the radial direction, the collar 34 of the cylinder ampoule 7 can pass through the protruding portion of the latch tongue 32. The syringe 8 then initially remains in the first access opening 28.

  The first access opening 28 includes a guide 68 for the cannula element 40, which guides the cannula element 40 so that the cannula 44 enters the plug or septum of the cylinder ampoule 7 in a predetermined position. . At this time, the guide is preferably selected so that the cannula 44 is off center and enters the septum of the cylinder ampoule 7. That is, the guide 68 is slightly displaced in the radial direction with respect to the central axis of the first accommodating portion 24 in the longitudinal axis or the central axis. This acts so that the diaphragm of the cylinder ampule 7 is pierced at a different point from when the cylinder ampule 7 is used later in the pen system.

  Next, as shown in FIG. 20, the syringe 8 is removed again from the opening 58 of the closure element 6. In so doing, the luer taper 14 of the syringe 8 is again separated from the luer connector 42 of the cannula element 40, since the cannula element 40 is retained by the elastic tongue 60 as described above. Subsequently, the syringe 8 can be inserted into the third housing portion 64 (see FIG. 7) in the housing 4. A fastening element 66 is formed in the third accommodating portion 64 so as to fit the luer taper 14, and the luer taper 14 is fastened to the fastening element 66. In this state, the syringe 8 is fixed in the housing 4. At the same time, the cannula element 40 is fixed between the closure element 6 and the housing 4 as described above, and the emptied container 18 is fixed to the second receptacle 26. In this state, the holding device 2 can be discarded together with the cannula element 40 and the container 18 of the syringe 8.

2 Holding device 4 Housing 6 Closing element 7 Cylinder ampoule 8 Syringe 10 Cylinder 11 Piston 12 Piston rod 14 Luer taper 16 Cap 18 Container 20 Diaphragm 22 Collar 24 First accommodating part 26 Second accommodating part 28 First access opening 30 First Two access openings 32 Latch tongue 34 Collar 36 Latch tongue 38 Holding means 40 Cannula element 42 Luer connector 44 Cannula 46 Guide groove 48 Protrusion 50 Tongue piece 52 Protrusion part 54 Opening 56 Side edge 58 Opening 60 Elastic tongue piece (Securing means)
62 Piston 64 Third housing portion 66 Clamping elements E1, E2 Insertion direction S Displacement direction

Claims (19)

A filling aid for filling the cylinder ampoule (7) with medical liquid or pharmaceutical liquid,
In a common housing (4), a first accommodating part (24) formed so as to accommodate the cylinder ampoule (7) to be filled, and a container (18) containing a medical substance or a medicinal substance A second accommodating portion (26) formed to accommodate,
When the cylinder ampoule (7) is inserted into the first housing part (24), the first housing part (24) faces the opening of the cylinder ampoule (7). A first access opening (28) is formed,
The second container (26) is disposed so as to face the opening of the container (18) when the container (18) is inserted into the second container (26). A filling aid in which a second access opening (30) is formed.   A fixing means (32) is provided in the first housing portion (24) so as to be removably fixed to the cylinder ampoule (7) in the first housing portion (24). The filling aid according to claim 1, which is arranged.   The cylinder ampoule (7) is pre-assembled and detachably fixed in the first accommodating part (24) by the fixing means (32), and is taken out from the first accommodating part (24). The filling aid according to claim 2, which is possible.   The second container (26) is provided with the container (18) containing a medical substance or a pharmaceutical substance so as to be detachably fixed in the second container (26). The filling aid according to any one of claims 1 to 3, wherein fixing means (36) are arranged.   A cannula element (40) comprising a cannula (44) and a luer connector (42) is removably retained in the second receptacle (26), and the luer connector (40) of the cannula element (40) is retained. 42) faces the second access opening (30) so that the cannula (44) enters the container (18) inserted into the second receiving part (26). The filling aid according to any one of claims 1 to 4, which is oriented.   The filling aid according to claim 5, wherein the second access opening (30) is dimensioned so that the cannula element (40) can be removed through the second access opening (30).   Arranged in the second receptacle is at least one holding means (38) for releasably securing the cannula element (40), the holding means (38) being arranged in the longitudinal direction of the cannula (44). The filling aid according to claim 4 or 5, wherein a holding force smaller than a force that can be transmitted in the longitudinal direction by the luer connector (42) is generated.   8. A syringe (8) according to any one of claims 4 to 7, comprising a syringe (8) separated from the housing (4) and having a luer taper (14) engageable with a luer connector (42) of a cannula element (40). The filling aid described.   The filling aid according to any one of claims 1 to 8, wherein the housing (4) comprises a third housing part (64) configured to house and secure a syringe (8).   The first access opening (28) is dimensioned such that a cannula element (40) can be inserted through the first access opening (28) into the first receiving part (24). The filling aid according to any one of? 9.   The cannula element (40) inserted through the first access opening (28) is fixed in the first receiving part (24) by the first access opening (28). The filling aid according to claim 10, wherein at least one securing means formed is arranged.   12. A filling aid according to claim 11, wherein the at least one securing means is formed as an elastic tongue (60).   A closure element (6) movable between a first position and a second position, said closure element closing said first access opening (28) in said first position and said 13. Opening a second access opening (30), closing the second access opening (30) and opening the first access opening (28) in the second position. The filling aid according to any one of the above.   The closure element (6) comprises at least one releasable locking part (50, 52), which locks the closing element (6) in at least one of the first position and the second position. The filling auxiliary tool according to claim 13, wherein the filling aid is releasably fixed to either side and can be released with one hand.   Filling according to any of the preceding claims, wherein the first access opening (28) and the second access opening (30) are arranged on the same side of the housing (4). Auxiliary tool.   The first accommodating portion (24) having the first access opening (28) and the second accommodating portion (26) having the second access opening (30) are the first access opening. (28) and the insertion direction (E1, E2) of the second access opening (30) are arranged and formed to extend in parallel with each other, and at least one of the cannula element (40) and the syringe (8) A filling aid according to any one of the preceding claims, wherein can be inserted into the first and second access openings (28, 30) along the insertion direction. A method for filling a cylinder ampoule (7) with a medical liquid or a pharmaceutical liquid using the filling aid according to any one of claims 1 to 16, comprising:
A container (18) having the medical or pharmaceutical liquid to be introduced into the cylinder ampoule (7) is inserted into or inserted into the second container (26);
A syringe (8) is inserted into the second access opening (30) and the medical or pharmaceutical liquid is aspirated from the container (18) into the syringe (8);
The syringe (8) is removed from the second access opening (30) and inserted into the first access opening (28);
Method wherein the medical or pharmaceutical liquid is transferred from the syringe (8) into a cylinder ampoule (7) arranged in the first container (24).   The container (18) initially contains a powdered medical substance or medicinal substance, and the substance is dissolved by the addition of a liquid, and the medical liquid or medicinal liquid is contained in the container (18). The method of claim 17, wherein:   The container (18) is initially filled with a powdered medical substance or medicinal substance, and a liquid for dissolving the substance before inserting the syringe (8) into the second access opening (30). Is filled into the syringe (8), and the syringe (8) is inserted into the second access opening (30), and then the liquid is transferred from the syringe (8) to the container (18) to form the powder. The method according to claim 18, wherein the substance is dissolved to form the medical or pharmaceutical liquid, and then the liquid is aspirated again into the same syringe (8) for transfer into the cylinder ampoule (7). .